Testing on Orphans

Now that I have your attention, let me explain. I have long considered gaskets and diaphragms to be the orphans of the bioprocessing industry. My analogy isn’t perfect, but bear with me. When measured in square inches, they collectively make up a tiny fraction of a process line and are nearly forgotten, but processes cannot function without them. Neglected and underestimated, they try to manage the task of creating perfect seals to prevent contamination and leakage. When something inevitably goes wrong, they are the prime suspects. It doesn’t matter if a system is comprised mostly of stainless steel or of single-use parts, when there is a failure, all fingers point to the tiny orphans that are just trying to do their jobs. The problem is, they may have been forced into a situation for which they were not intended.

The materials used to manufacture these orphans (elastomers and thermoplastics) will not change in the foreseeable future. It is important to acknowledge that they behave in different ways and therefore the applications for which they are used need to be suited to their inherent qualities. Most gaskets and diaphragms work well. If they fail, it is usually because of misapplication. Either they are asked to do something they weren’t meant to do, they were installed wrong, or they were used past their suggested service life.

How much trouble could a misapplied gasket possibly cause? Let’s ask the astronauts who took the last trip on the Challenger space shuttle. Well, we would if we could. But the fact is that the 306 ton behemoth they were riding in was brought down by an O-ring operating in a process condition outside of its specifications. The O-ring was not intended for exposure to freezing conditions and a rare Florida frost damaged it with catastrophic consequences.

In that case, the component and the process were not a match.

The process is king. End users and manufacturers must match process knowledge with component knowledge in order to ensure that the components do their jobs and the process lets them. Component manufacturers often don’t understand process stresses and data. Before installation, we must ask does this component meet the requirements of this process? Sounds simple, but how do we know when the answer is yes? How can we compare specifications against capabilities? Simple. Through experience or testing.

Experience is crucial for collecting knowledge about anything. However, in the bioprocess industry, the days of pilot plants are long gone and regulation resultant from experience doesn’t always serve a purpose. Harvesting the collective experience of the industry would appear to be the most beneficial, but there are forces working against this such as competition. Successful companies don’t want their competitors borrowing their process line playbooks.

Is it the end user’s responsibility to find the best gasket for their process? Or is it the supplier’s responsibility to understand how their product should be used and make the end user aware of its strengths and limitations. The answer is both, but how would such information sharing take place?

The natural evolution of experience takes us from guidelines to standards and eventually to regulations, but even these are not fully comprehensive and can lead to confusion. This leaves end users to figure it out for themselves by pitting their own budgetary restrictions against their suppliers’ marketing claims. Most component manufacturers don’t understand process stresses and data, and most end users don’t understand the mechanical design aspects for withstanding certain process conditions. As Steve Jobs once said, ‘Design is not just what it looks like and feels like. Design is how it works.’

The main job of a gasket or a diaphragm is to keep fluid in and bacteria and particulate out. As with terrorism, you can set up security protocols to try to keep the bad guys from crossing your border. At the airport, we take off our shoes, throw away liquids, and empty our pockets. In bioprocessing, we use clean rooms, gloves, quality control and sterilization. In both cases, precautions help us feel safe, but do they really make us safe? In order to prevent an airport breech, you have to think like a terrorist. In order to prevent a process breech, you have to think like a bacterium. You have to know your process inside and out to understand where problems can exist. This is most important with gaskets and other seals. A safe border equals a safer process.

If experience isn’t the answer, then testing is. As I mentioned earlier, misapplication is the biggest problem faced by end users. The best way to avoid misapplication of a component is to understand it better by acquiring reproducible data and test methods through performance and exposure testing. But unless the testing is robust and identical across the board, it isn’t valuable. To date, a standard method for testing does not exist, and if everyone is using a homemade yard stick you might as well not measure at all.

Certain industry consortia have emerged for one side of the equation or the other to address the issue of testing by borrowing tactics from other industries. But what they are asking of the bioprocessing industry does not necessarily marry process knowledge and component knowledge with reproducible data and testing methods because they are making rules from only one viewpoint instead of both.

Processes must be designed while keeping in mind how they are wed to the components they use. Qualification and validation are crucial steps in the design of your process, but proper testing can provide a foundation to minimize those steps and give you the rationale and understanding for the best design of your process.

Airports come up with rules after something goes wrong. We never removed our shoes at security checkpoints before a terrorist attempted to blow up a plane with explosives hidden in the heel of his shoe. Performance testing helps you understand your process and component limitations before an event occurs. Airports perform drills to think like a terrorist. We must perform testing in order to think like bacteria.

At The BioProcess Institute, we like to force failures in simulated processes to study the causes and effects. In our case, catastrophic gasket failure usually results in some great video footage, a few paragraphs in our BioProcess Performance Report, and a mop and bucket. In a pharmaceutical company, this same failure could jeopardize revenue, jobs, and, in the worst case, patients’ lives.

We help clients on both sides of the equation: process and component. Our testing provides data and our expertise interprets that data to produce understanding. If you want to know which gasket is ideal for your process, we can help you. If you want to know why, we’d love to tell you that, too.

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